Every year in the UK, around 20,000 people, mostly teenagers and young adults, tear their anterior cruciate ligaments (ACLs). These injuries, common in sports like football and skiing, not only cause significant pain but can also lead to long-term issues such as osteoarthritis. Current surgical solutions often involve harvesting tendons from the patient's body to reconstruct the torn ligament, leading to additional pain and complications.
Researchers at NDORMS, University of Oxford, have developed a potential solution. They are testing the safety and effectiveness of a braided, electrospun cord made of a biocompatible polymer that is safe to use in the body. This synthetic implant, called BioLig, is designed to provide the mechanical stability of a reconstructed ACL while also encouraging the patient's own cells to grow into and repair the torn ligament.
Project lead Associate Professor Pierre-Alexis Mouthuy said: ‘We have created an off-the-shelf, degradable implant that is designed to reconstruct and regenerate a patient’s ACL to restore knee function. Through this new large animal trial, we aim not only to demonstrate the safety and effectiveness of the implant but also to show that it performs as well as or better than autografts, the current gold standard in ACL reconstruction. If successful, this could lead to faster recovery times and a reduced risk of long-term complications like osteoarthritis.’
The team has already shown in pilot studies that BioLig can be implanted using standard ACL reconstruction techniques and that the device encourages tissue growth throughout its structure. Now, with the new funding from the UKRI-MRC Developmental Pathway Funding Scheme, the team will conduct a robust in-vivo ovine study over 12 months to assess the implant's safety and ability to restore normal knee mechanics.
The research team draws from multiple specialities at NDORMS, including engineering, clinical science, statistics, and biology. The project also involves external collaborators such as the Royal Veterinary College (RVC), the University of Portsmouth, and regulatory experts. The device will be manufactured in the newly established cleanroom at the Botnar Institute.
Andrew Price, Professor of Orthopaedics Surgery at NDORMS is the clinical lead for the study. He said: ‘If the results from this large study are positive, it will be a major step forward in developing BioLig as a viable alternative to traditional ACL reconstruction that we can then take to human trial. I’m particularly excited by the prospect as it has the potential to improve the care we deliver to our patients in a cost effective way for the NHS.’
The researchers will also engage with the target patient population - teenagers and young adults under 30 - to incorporate their feedback as the project progresses. Obtaining the patient perspective will be crucial to ensure BioLig meets the needs of this active group.